Job Title:
Pharmacovigilance Associate / Senior Pharmacovigilance Associate
Job Reference: JR127208
Location: Chennai (Full Service & Corporate Support Office or Home-Based)
Department: Drug Safety
Employment Type: Full-time
About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organization. We are committed to innovation, inclusion, and excellence in clinical development, providing employees with an inclusive environment that supports professional growth and success.
Role Overview
As a PV Associate or Sr PV Associate, you will play a key role in managing and analyzing safety data for pre- and post-marketed products, ensuring compliance with global pharmacovigilance regulations and client-specific procedures.
Key Responsibilities
Safety Case Processing & Review
Review and process safety events (pre-marketing, post-marketing, medical devices, and drugs)
Perform literature surveillance (abstract/full article reviews) to identify relevant safety information
Perform safety review of clinical and diagnostic data
Generate accurate data listings from safety databases
Safety Communication & Documentation
Complete follow-up activities via phone or written communication with reporters/sites
Maintain project safety tracking systems and ensure data accuracy
Liaise with investigational sites, sponsors, and ICON stakeholders on safety matters
Project Management & Oversight
Assist in the development and maintenance of Safety Management Plans (SMP)
Contribute to creation of PSMF, RMP, and PBRER documents
Participate in safety data reconciliation and interim data analysis for DMC reviews
Attend project meetings, sponsor calls, and investigator meetings as needed
Regulatory Reporting & Signal Detection
Support the generation of aggregate safety reports (DSUR, IND Annual Reports, PSUR, etc.)
Assist Safety Scientists in signal detection and risk management activities
Identify out-of-scope project activities and recommend solutions
Compliance & Quality Assurance
Ensure safety database is maintained with high quality and accuracy
Support audit and inspection readiness and participate as required
Respond to medical information inquiries, including those related to AEs and product complaints
Candidate Profile
Qualifications:
Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Advanced degree preferred)
Experience:
Prior experience in pharmacovigilance, drug safety, or related clinical/pharmaceutical areas
Familiarity with global PV regulations and guidelines
Skills:
Strong analytical and data management skills
Attention to detail and commitment to quality
Excellent written and verbal communication skills
Effective interpersonal and cross-functional collaboration abilities
What ICON Offers
Competitive Salary and country-specific benefits
Health & Wellness: Comprehensive insurance plans for you and your family
Retirement Planning with competitive savings options
Paid Time Off: Various annual leave entitlements
Employee Assistance Program (EAP): 24/7 global mental health and wellbeing support
Flexible Benefits: Optional perks like childcare vouchers, gym discounts, travel passes, and more
Inclusive Culture: A strong focus on diversity, equity, inclusion, and belonging
Global Opportunities: Room for growth and internal mobility
Additional Information
Hiring Manager: Archana Bakkiyarajan
Application Options: Apply online or message Archana directly if you have inquiries
Accessibility Support: Reasonable accommodations available for candidates with medical conditions or disabilities
How to Apply
Click the Apply button or visit ICON’s Careers Site to submit your application. If you are already an ICON employee, please use the internal application link.
Not sure if you meet all the requirements?
We still encourage you to apply—your unique profile may be exactly what we need, either for this role or another at ICON.
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